Responsibilities:

• Supervise and direct the overall performance and effectiveness of QC Laboratory to ensure QC activities fulfill PIC/S and FDA GMP requirements.
• Prepare and implement QC department annual plan
• Direct, guide and manage QC team to enhance their sensitivity and profession on quality issue
• Plan and execute QC quality activity plan annually
• Responsible for enhancing data integrity compliance of QC department
• Responsible for daily QC laboratory operations and to ensure all operations are in full compliance with applicable SOPs, GMP requirements and safety guidelines.
• Provide effective leadership including setting individual and department objectives, employee evaluations, leading departmental meetings, providing performance feedback, recognizing employee contributions, coaching and developing staff.
• To support and supervise QC responsibilities for the performance of all in-process, finished product, process validation, method validation and stability testing.
• Provide guidance and risk assessment for the resolution of discrepancies, OOS, unexpected results, lab investigations and Corrective and Preventative Actions.
• Oversee all aspects relating to the QC instrumentation program including; purchase, installation, qualification, PM scheduling and trouble shooting.
• In charge of continuous improvement to the lab in regards to instrument and method life cycle management.
• Interact with internal and external colleagues, regulatory agencies and internal auditors.
• Represent QC at operational and cross-functional meetings; prepares and presents information, provides decision making support at meetings and disseminates information back to QC.
• Responsible for evaluating new technologies and requirements and implementing them as needed to stay current with best practices and new regulatory demands.
• Responsible to manage department staff and HR related issues.

Requirements:

• Bachelor degree or above in chemistry, biology, microbiology and/ or life sciences
• Minimum 5 years pharmaceutical experience/laboratory management and/or related pharmaceutical experience.
• Thorough knowledge of cGMPs and pharmaceutical manufacturing requirements. Demonstrated auditing and corrective action proficiency.
• Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues.
• Demonstrated proficiency of root cause analysis as applied in a pharmaceutical manufacturing environment.
• Knowledge of document management/quality systems
• Building relationships with other departments
• Statistical Analysis capability